NCT00735631已完成4 期
Evaluation of the Accuracy, Safety and Robustness of a Single-input-single-output (SISO) Model-based Predictive Closed-loop System to Guide Patient-individualized ICU Sedation.
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- The propofol and remifentanil dose needed to keep the BIS within the target range
研究概览
简要总结
The aim of this study is to investigate the accuracy, safety and robustness of a single-input-single output (SISO) model-based predictive closed-loop system to guide patient-individualized ICU sedation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients in the immediate post-operative phase after an coronary artery reconstruction surgery.
- •age >= 18 years
- •informed consent obtained before the surgery
排除标准
- •severe renal failure defined by the RIFLE Classification levels Risk, Failure and End-stage Kidney Failure
- •severe hepatic failure defined by a bilirubin level of >= 3 mg/dl and/or a prothrombin level of < 50% before the surgery
- •low ejection fraction defined as < 40%
- •age < 18 years
- •postoperative bleeding so that a new surgery is necessary
- •history of cardiovascular accident (CVA)
- •history of COPD
- •age > 75 years
- •postoperative cardiac index < 2.2 for more than 2 hours
- •SvO2 < 60% for more than 2 hours
- •hypotension with a MAP < 60 mmHg for more than 2 hours
- •sedation agents other than remifentanyl and propofol including also Catapressan, Risperdal, Etumine
- •Remifentanyl dose exceeding 0.5 µg/kg/min.
- •absence of informed consent
研究组 & 干预措施
1
Experimental
The single-input-single-output (SISO) model-based predictive closed-loop system will be used to guide patient-individualized ICU sedation with propofol
干预措施: SISO model-based predictive closed-loop system (Device)
结局指标
主要结局
The propofol and remifentanil dose needed to keep the BIS within the target range
时间窗: During sedation
次要结局
- The hemodynamic stability of the patient, being defined as: - mean arterial blood pressure between 65 and 85 - heart rate around 80 beats'/min - diuresis 0.5 - 1 ml/kg/hour - normal pH - normal cardiac index as defined by a CI > 2.2 - Sv02 > 60 %(During sedation)
研究者
研究点 (1)
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